HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B

K082202 · Barrx Medical, Incorporated · GEI · Oct 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082202
• Device Name: HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
• Applicant: Barrx Medical, Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. The HALO360 Energy Generator is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Device Story

HALO360 Energy Generator is an electrosurgical coagulation system used in the gastrointestinal tract. System components include the energy generator, disposable HALO60 coagulation catheter, output cable, and optional footswitch. Device delivers energy to coagulate tissue at bleeding or non-bleeding sites. Operated by clinicians in a clinical setting. Software version 4.5 introduces modifications to coagulation catheter operating pressure. Output is controlled energy delivery for tissue coagulation; healthcare providers use this to treat specific GI lesions. Benefits include effective hemostasis and treatment of esophageal conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrosurgical coagulation system. Components: energy generator, disposable single-use coagulation catheter, output cable, optional footswitch. Software-controlled energy delivery. Modification to coagulation catheter operating pressure implemented in software version 4.5.

Indications for Use

Indicated for coagulation of bleeding and non-bleeding gastrointestinal tract sites, including esophagus. Specific conditions: Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• HALO360 Energy Generator model 1100C-115B software version 4.2 (K051168)
• Stellartech Coagulation System 2, model 1100C-115A (K050831)

Submission Summary (Full Text)

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# OCT 0 8 2008

### 510(k) SUMMARY

# BÂRRX Medical's HALO360 Energy Generator

### Submitter's Name, Address, Telephone Number, Contact 1. Person, and Date Prepared:

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

Phone: [phone] Facsimile: [phone]

Contact Person: Viorica Filimon

Date Prepared: August 1, 2008

#### Name of device and Name/Address of Sponsor: 2.

HALO360 Energy Generator

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

#### 3. Common or Usual Name(s):

Electrosurgical Coagulation System

#### Classification Name: 4.

Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery

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#### 5. Predicate Devices

HALO360 Energy Generator model 1100C-115B software version 4.2 (K051168) manufactured by Stellartech Research;

Stellartech Coagulation System 2, model 1100C-115A (K050831) manufactured by Stellartech Research;

#### 6. Intended Use / Indications for Use

The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360 Energy Generator is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

#### Technological Characteristics 7.

The HALO360 Coagulation System consists of the HALO360 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2.

### HALO360+ Coagulation Catheter

There are no changes associated to the HALO360+ Coagulation Catheter.

### HALO360 Energy Generator

The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.

There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) k050831 and k051168. There are minor changes implemented to the software version of the generator.

This submission addresses software changes for HALO360 Energy Generator cleared by the 510(k) k050831 and k051168. These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy.

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### Substantial Equivalence

The HALO360 Energy Generator model 1100C-115B (software version V4.5) and the predicate devices HALO360 Energy Generator model 1100C-115B (software version 4.2), and Stellartech Energy Generator 2 have the same intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO360 Energy Generator model 1100C-115B software version 4.5 and its predicates are:

> Modification of the coagulation catheter operating pressure .

The differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Barrx Medical. Inc. % Ms. Viorica Filimon VP of Quality/Regualtory Affairs 540 Oakmead Parkway Sunnyvale, California 94085

Re: K082202

Trade/Device Name: The HALO360 Energy Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 5, 2008 Received: September 9, 2008

Dear Ms. Filimon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Viorica Filimon

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Mulhern

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

The HALO360 Energy Generator is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

N.L.R.R. Ryden for mkm

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K082202 Page 1 of 1

HALO360 Energy Generator